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This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution) |
|
| 2 | Placebo Comparator | Physiologic saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIR645 | Drug | AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measures of the safety and tolerability of AIR645 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, pulmonary function tests, heart rhythm, and laboratory tests. | During dosing and for two weeks after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability | During dosing and for two weeks after dosing |
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Inclusion Criteria*:
Exclusion Criteria*:
Clinically significant medical history or condition which precludes participation
Clinically significant ECG abnormality
Clinically significant VS or PE abnormality
Clinically significant screening lab abnormality
Abnormal lung function (FEV1 <80% predicted)
Respiratory infection within 14 days of randomization
HBV, HCV, or HIV
Breastfeeding or pregnant female
History of alcohol abuse or illicit drug use within past 24 months
Use of any tobacco or nicotine-containing product within past 6 months
Use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol
Use of any investigational drug within past 30 days
Use of any investigational monoclonal antibody or recombinant protein within past 90 days
Donation of plasma within past 7 days
Donation or loss of whole blood within past 56 days
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| Name | Affiliation | Role |
|---|---|---|
| Mike Hodges, MD | Altair Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contract Research Organization (CRO) appointed by Altair Therapeutics--Altair's offices are in: | San Diego | California | 92130 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Physiologic saline solution | Drug | Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days. |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |